Module 5 Presentations

18/07/2024

Formal PMDA Consultation

Important Milestone for development in Japan Labour – intensive

Takes 2h Meeting held in Japanese language with the presence of Interpreters 2 months pre-notice Costly(depending on the type of consultation) Minutes prepared by PMDA and reviewed by Sponsor

Distribution to third parties is not allowed

29

PMDA Consultation Timelines

Sponsor/company

Consultation Request sent to PMDA

Submit F2F

Submit Briefing Document

Response within 5 w. days

Response within 5 w. days

Present. material

-2 M

-5 W -4 W

-3 W

-10D

F2F

-2 D

PMDA confirms date

Receive PMDA queries

PMDA Preliminary Opinion

PMDA Distribution to third parties is not allowed

30

15